mdi Consultants
FDA announces the MDUFA fees for FY 2020.
The FDA announced its fee rates and payments procedures for medical device user fees for the FY 2020. Fee rates for FY 2020 were adjusted for inflation. The fee rates go into effect from October 1, 2019 to September 30, 2020.The application fee should be paid for at the time of submission to avoid delays. The fee you must pay is the fee that is in effect at the time your application is received by the FDA or the date your fee payment is recognized by the U.S. Treasury. Small businesses may qualify for a reduced fee.
Medical Device Fees for FY 2020:
| Application Type | Standard Fee 2020 | Standard Fee 2019 | Small Business Fee 2020 | Small Business Fee 2019 |
| 510(k) | $11,594 | $10,953 | $2,899 | $2,738 |
| 513(g) | $4,603 | $4,349 | $2,302 | $2,175 |
| De Novo classification | $102,299 | $96,644 | $25,575 | $24,161 |
| PMA, PDP, PMR, BLA | $340,995 | $322,147 | $85,249 | $80,537 |
| panel-track supplement | $255,747 | $241,610 | $63,937 | $60,403 |
| 180-day supplement | $51,149 | $48,322 | $12,787 | $12,081 |
| real-time supplement | $23,870 | $22,550 | $5,968 | $5,638 |
| BLA efficacy supplement | $340,995 | $322,147 | $85,249 | $80,537 |
| Annual Report | $11,935 | $11,275 | $2,984 | $2,819 |
| 30-day notice | $5,456 | $5,154 | $2,728 | $2,577 |
When comparing FY 2020 fee rates to last year’s fiscal year rates, it’s important to note that there was an average increase of 5.85% in fees.
mdi Consultants has been involved with many clients on various projects and specializes in dealing with medical device applications like 510(k)s and PMAs, reports and other FDA documentation. mdi Consultants has successfully submitted over 3500 510(k) clearance for our clients. If you need any assistance with FDA applications or other regulations, please contact us for a free consultation.
We will continue to monitor any updates pertaining to medical device user fee rates moving forward. If you have any questions about user fee rates and the FDA, how this can affect your company, or for any of your regulatory requirements feel free to contact us at [email protected] or use our contact form.